First-line use of Pfizer’s Bosulif cleared in the US

The decision comes on the back of data from a Phase III trial funded and conducted by UK group Avillion under a collaborative development agreement with the drugs giant.

The BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) study showed that Bosulif (bosutinib) 400mg was linked with a significantly higher rate of patients achieving major molecular response (MMR) at 12 months (47.2 percent) compared to the rate achieved in patients treated with imatinib 400mg (36.9 percent), a current standard of care.

Complete cytogenic response (CCyR) rate by 12 months was 77.2 percent for patients treated with Bosulif compared to 66.4 percent for patients treated with imatinib, with time to CCyR shorter for patients treated with Bosulif.

“Molecular targeted therapy has substantially improved outcomes of patients with CML over that last two decades. Due to its efficacy and distinct tolerability profile, Bosulif significantly expands our treatment options for newly diagnosed CML patients,” said Prof. Tim Brümmendorf, director of the Clinic for Oncology, Haematology and Stem Cell Transplantation at the Euregionales Comprehensive Cancer Center Aachen (ECCA), and European lead investigator on BFORE.

Bosulif was first approved in September 2012 in the US for the treatment of adult patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.

“Bosulif was Pfizer’s first treatment for hematologic malignancies, and has since become an important treatment option for Ph+ CML patients who are resistant or intolerant to previous therapy. This expanded indication has the potential to make an even greater impact on the lives of patients with CML,” said Liz Barrett, global president, Pfizer Oncology.

US approval of the drug in this setting has triggered milestone payments  to Avillion as per the companies’ agreement.

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